AbbVie and Gedeon Richter Announce New Collaboration for the Discovery and Development of Novel Targets for Neuropsychiatric Conditions
AbbVie and Gedeon Richter have announced a new discovery, co-development and license agreement for novel neuropsychiatric treatments. The collaboration expands their nearly two-decade partnership in CNS projects. Under the agreement terms, Richter will receive a $25 million upfront payment plus potential future milestones and sales-based royalties. AbbVie gains worldwide commercialization rights except for Richter's traditional markets including Europe, Russia, CIS countries, and Vietnam. The partnership builds on previous successes including cariprazine and investigational drug ABBV-932 for bipolar depression and anxiety disorder.
AbbVie e Gedeon Richter hanno annunciato una nuova scoperta, un accordo di co-sviluppo e licenza per nuovi trattamenti neuropsichiatrici. La collaborazione amplia la loro partnership che dura da quasi due decenni nei progetti sul sistema nervoso centrale. Secondo i termini dell'accordo, Richter riceverà un pagamento iniziale di 25 milioni di dollari più potenziali traguardi futuri e royalties basate sulle vendite. AbbVie ottiene diritti di commercializzazione a livello mondiale, ad eccezione dei mercati tradizionali di Richter, tra cui Europa, Russia, paesi CSI e Vietnam. La partnership si basa su successi precedenti, inclusi cariprazina e il farmaco investigativo ABBV-932 per la depressione bipolare e il disturbo d'ansia.
AbbVie y Gedeon Richter han anunciado un nuevo descubrimiento, un acuerdo de co-desarrollo y licencia para nuevos tratamientos neuropsiquiátricos. La colaboración amplía su asociación de casi dos décadas en proyectos del sistema nervioso central. Según los términos del acuerdo, Richter recibirá un pago inicial de 25 millones de dólares más hitos futuros y regalías basadas en ventas. AbbVie obtiene derechos de comercialización a nivel mundial, excepto en los mercados tradicionales de Richter, que incluyen Europa, Rusia, los países de la CEI y Vietnam. La asociación se basa en éxitos previos, incluyendo la cariprazina y el medicamento en investigación ABBV-932 para la depresión bipolar y el trastorno de ansiedad.
AbbVie와 Gedeon Richter가 새로운 발견과 공동 개발 및 라이센스 계약을 발표했습니다. 이 협력은 CNS 프로젝트에서 거의 20년에 걸친 파트너십을 확대합니다. 계약 조건에 따라 Richter는 2,500만 달러의 선불 금액과 함께 미래의 성과 및 판매 기반 로열티를 받을 것입니다. AbbVie는 유럽, 러시아, CIS 국가, 베트남을 포함한 Richter의 전통 시장을 제외한 전 세계 상업화 권리를 획득합니다. 이 파트너십은 양극성 우울증과 불안 장애를 위한 카리프라진과 연구 중인 약물 ABBV-932를 포함한 이전 성공에 기반합니다.
AbbVie et Gedeon Richter ont annoncé une nouvelle découverte, un accord de co-développement et de licence pour de nouveaux traitements neuropsychiatriques. La collaboration élargit leur partenariat de près de deux décennies dans les projets de SNC. Selon les termes de l'accord, Richter recevra un paiement initial de 25 millions de dollars ainsi que des jalons futurs et des redevances basées sur les ventes. AbbVie obtient des droits de commercialisation dans le monde entier, à l'exception des marchés traditionnels de Richter, comprenant l'Europe, la Russie, les pays de la CEI et le Vietnam. Ce partenariat s'appuie sur des réussites antérieures, y compris la cariprazine et le médicament expérimental ABBV-932 pour la dépression bipolaire et le trouble anxieux.
AbbVie und Gedeon Richter haben eine neue Entdeckung sowie eine Vereinbarung über gemeinsame Entwicklung und Lizenzierung für neuartige neuropsychiatrische Behandlungen bekannt gegeben. Die Zusammenarbeit erweitert ihre fast zwei Jahrzehnte währende Partnerschaft in Projekten des zentralen Nervensystems. Gemäß den Bedingungen der Vereinbarung erhält Richter eine 25 Millionen Dollar Vorauszahlung sowie zukünftige Leistungsziele und auf Verkäufen basierende Royalties. AbbVie erlangt die weltweiten Vermarktungsrechte, ausgenommen Richter's traditionelle Märkte, einschließlich Europa, Russland, GUS-Länder und Vietnam. Die Partnerschaft baut auf früheren Erfolgen auf, einschließlich Cariprazin und dem Prüfpräparat ABBV-932 für bipolare Depression und Angststörungen.
- Secured $25 million upfront payment for Richter
- Expansion of successful existing partnership in CNS drug development
- Potential additional revenue through development, regulatory and commercialization milestones
- Future sales-based royalties opportunity
- Worldwide commercialization rights secured for AbbVie (except specific markets)
- Shared financing requirements for R&D activities
- geographical commercialization rights in key markets like Europe
Insights
The collaboration between AbbVie and Gedeon Richter marks a significant strategic expansion in the neuropsychiatric drug development space. The
The deal structure is particularly advantageous for AbbVie, securing worldwide commercialization rights except in Richter's traditional markets. This geographic split optimizes market access while leveraging each company's established distribution networks. The shared R&D financing model helps distribute development risks while maintaining strong alignment between partners.
This collaboration addresses critical gaps in neuropsychiatric treatment options. The focus on novel targets suggests potential breakthrough approaches beyond traditional mechanisms of action. Building upon the success of cariprazine (VRAYLAR), which has shown efficacy across multiple indications including MDD, bipolar disorder and schizophrenia, this partnership could yield next-generation therapeutics with improved efficacy or safety profiles.
The inclusion of ABBV-932 for bipolar depression and anxiety demonstrates the partnership's ability to advance candidates through clinical development. The emphasis on both preclinical and clinical activities indicates a robust pipeline approach that could yield multiple therapeutic candidates.
- Companies will discover and develop novel targets for the potential treatment of neuropsychiatric conditions
- New discovery program builds upon nearly two decades of partnership between AbbVie and Gedeon Richter
"There remains a large unmet need for people living with neuropsychiatric disorders, making it imperative that we continue to innovate and pursue novel targets and approaches to discover and develop new therapies," said Jonathon Sedgwick, Ph.D., senior vice president and global head of discovery research, AbbVie. "We are excited to expand our longstanding and successful partnership with Richter to help address the complex needs of these patients."
"This new agreement builds on years of successful partnership allowing Richter to further support AbbVie's global ambition in neuropsychiatry and validates the quality of science behind our unique discovery platform," said Gábor Orbán, chief executive officer of Gedeon Richter.
Under the terms of the agreement, the collaboration includes both preclinical and clinical R&D activities with shared financing by the parties. Richter will receive an upfront cash payment of
VRAYLAR® (cariprazine) US Uses and Important Safety Information
VRAYLAR is a prescription medicine used in adults:
- along with antidepressant medicines to treat major depressive disorder (MDD)
- for short-term (acute) treatment of manic or mixed episodes that happen with bipolar I disorder
- to treat depressive episodes that happen with bipolar I (bipolar depression)
- to treat schizophrenia
What is the most important information I should know about VRAYLAR?
Elderly people with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) taking medicines like VRAYLAR are at an increased risk of death. VRAYLAR is not approved for treating patients with dementia-related psychosis. VRAYLAR and antidepressants may increase suicidal thoughts or actions in some children and young adults especially within the first few months of treatment or when the dose is changed. Depression and other mental illnesses are the most important causes of suicidal thoughts and actions. Patients on antidepressants and their families or caregivers should watch for new or worsening depression symptoms, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when VRAYLAR or the antidepressant is started or when the dose is changed. Report any change in these symptoms immediately to the doctor.
VRAYLAR may cause serious side effects, including:
• Stroke (cerebrovascular problems) in elderly people with dementia-related psychosis that can lead to death
• Neuroleptic malignant syndrome (NMS): Call your healthcare provider or go to the nearest hospital emergency room right away if you have high fever, stiff muscles, confusion, increased sweating, or changes in breathing, heart rate, and blood pressure. These can be symptoms of a rare but potentially fatal side effect called NMS. VRAYLAR should be stopped if you have NMS.
• Uncontrolled body movements (tardive dyskinesia or TD): VRAYLAR may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop taking VRAYLAR. Tardive dyskinesia may also start after you stop taking VRAYLAR.
• Late-occurring side effects: VRAYLAR stays in your body for a long time. Some side effects may not happen right away and can start a few weeks after starting VRAYLAR, or if your dose increases. Your healthcare provider should monitor you for side effects for several weeks after starting or increasing dose of VRAYLAR.
• Problems with your metabolism, such as:
− High blood sugar and diabetes: Increases in blood sugar can happen in some people who take VRAYLAR. Extremely high blood sugar can lead to coma or death. Your healthcare provider should check your blood sugar before or soon after starting VRAYLAR and regularly during treatment. Tell your healthcare provider if you have symptoms such as feeling very thirsty, very hungry, or sick to your stomach, urinating more than usual, feeling weak, tired, confused, or your breath smells fruity.
− Increased fat levels (cholesterol and triglycerides) in your blood: Your healthcare provider should check fat levels in your blood before or soon after starting VRAYLAR and during treatment.
− Weight gain: Weight gain has been reported with VRAYLAR. You and your healthcare provider should check your weight before and regularly during treatment.
• Low white blood cell count: Low white blood cell counts have been reported with antipsychotic drugs, including VRAYLAR. This may increase your risk of infection. Very low white blood cell counts, which can be fatal, have been reported with other antipsychotics. Your healthcare provider may do blood tests during the first few months of treatment with VRAYLAR.
• Decreased blood pressure (orthostatic hypotension): You may feel lightheaded or faint when you rise too quickly from a sitting or lying position.
• Falls: VRAYLAR may make you sleepy or dizzy, may cause a decrease in blood pressure when changing position (orthostatic hypotension), and can slow thinking and motor skills, which may lead to falls that can cause fractures or other injuries.
• Seizures (convulsions)
• Sleepiness, drowsiness, feeling tired, difficulty thinking and doing normal activities: Do NOT drive, operate machinery, or do other dangerous activities until you know how VRAYLAR affects you. VRAYLAR may make you drowsy.
• Increased body temperature: Do not become too hot or dehydrated during VRAYLAR treatment. Do not exercise too much. In hot weather, stay inside in a cool place if possible. Stay out of the sun. Do not wear too much clothing or heavy clothing. Drink plenty of water.
• Difficulty swallowing that can cause food or liquid to get into your lungs
Who should not take VRAYLAR?
Do not take VRAYLAR if you are allergic to any of its ingredients. Get emergency medical help if you are having an allergic reaction (eg, rash, itching, hives, swelling of the tongue, lip, face or throat).
What should I tell my healthcare provider before taking VRAYLAR?
Tell your healthcare provider about any medical conditions and if you:
• have or have had heart problems or a stroke
• have or have had low or high blood pressure
• have or have had diabetes or high blood sugar in you or your family
• have or have had high levels of total cholesterol, LDL-cholesterol, or triglycerides; or low levels of HDLcholesterol
• have or have had seizures (convulsions)
• have or have had kidney or liver problems
• have or have had low white blood cell count
• are pregnant or plan to become pregnant. VRAYLAR may harm your unborn baby. Taking VRAYLAR during your third trimester of pregnancy may cause your baby to have abnormal muscle movements or withdrawal symptoms after birth. Talk to your healthcare provider about the risk to your unborn baby if you take VRAYLAR during pregnancy. If you become pregnant or think you are pregnant during treatment, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or http://www.womensmentalhealth.org/clinicaland-research-programs/pregnancyregistry/.
• are breastfeeding or plan to breastfeed. It is not known if VRAYLAR passes into breast milk.
Talk to your healthcare provider about the best way to feed your baby during treatment with VRAYLAR. Tell your healthcare provider about all medicines that you take, including prescriptions, over-the counter medicines, vitamins, and supplements. VRAYLAR may affect the way other medicines work, and other medicines may affect how VRAYLAR works. Do not start or stop any medicines while taking VRAYLAR without talking to your healthcare provider.
What are the most common side effects of VRAYLAR?
• The most common side effects include difficulty moving or slow movements, tremors, uncontrolled body movements, restlessness and feeling like you need to move around, sleepiness, nausea, vomiting, indigestion, constipation, feeling tired, trouble sleeping, increased appetite, and dizziness.
These are not all the possible side effects of VRAYLAR.
Please see the full Prescribing Information, including Boxed Warnings, and Medication Guide.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube.
About Gedeon Richter
Gedeon Richter Plc. (www.gedeonrichter.com), headquartered in
Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2023 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
View original content to download multimedia:https://www.prnewswire.com/news-releases/abbvie-and-gedeon-richter-announce-new-collaboration-for-the-discovery-and-development-of-novel-targets-for-neuropsychiatric-conditions-302284729.html
SOURCE AbbVie
FAQ
What is the value of the upfront payment in AbbVie's (ABBV) new agreement with Gedeon Richter?
Which markets will AbbVie (ABBV) have commercialization rights for under the new agreement?
What therapeutic areas will the AbbVie (ABBV) and Gedeon Richter collaboration focus on?
What previous drugs have resulted from AbbVie (ABBV) and Gedeon Richter's partnership?
